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Reaction mass of 5,5'-{(phenylmethanediyl)bis[benzene-4,1-diyl-diazene-2,1-diyl]}bis{1-[3-(dimethylamino)propyl]-4-methyl-6-oxo-3-(pyridinium-1-yl)-1,6-dihydropyridin-2-olate} hydrochloride and 5,5’-[3,4’-(phenylmethanediyl)diphenylene]bis(diazene-2,1-diyl)bis{1-[3-(dimethylamino)propyl]-4-methyl-6-oxo-3-(pyridinium-1-yl)-1,6-dihydropyridin-2-olate} hydrochloride
EC number: 700-312-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2007-10-02 to 2007-12-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations, conducted with the analogue substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- analogue substance (refer to IUCLID chapter 13)
- IUPAC Name:
- analogue substance (refer to IUCLID chapter 13)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands, Postbus 6174, NL-5960 AD Horst / The Netherlands
- Age at study initiation: 11 weeks (male), 13 weeks (females)
- Weight at study initiation: First Day of Acclimatization: 2027, 2547, 2512 g; Last Day of Observation: 2697, 3377, 3346 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water ad libitum.
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2007-10-10 To: 2007-10-29
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with an electric clipper
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left flank
- % coverage:
- Type of wrap if used: test item was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after remocval of dressing the skin was flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- average of animals 1, 2, and 3
- Time point:
- other: overall at 1, 24, and 48 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 1 and 2
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- other: mean score for all three animals
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days at latest
- Other effects:
- VIABILITY/MORTALITY/CLINICAL SIGNS:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
IRRITATION: The skin assessment of all animals was prevented by a marked yellow staining produced by the test item 1-48 hours after treatment and persisted as slight staining up to day 14. When assessable at the 72-hour observation a very slight erythema was noted in one female, only. No oedema was present in all animals during the whole observation period.
COLORATION: A marked yellow staining produced by the test item was recorded in all animals at the 1-hour observation and persisted as slight staining up to day 14.
CORROSION:
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
BODY WEIGHTS: The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Erythema score could not be investigated in detail, as substance left a yellow staining on the treated skin. However based on the available data the substance still can be considered "not irritating". Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on the classification criteria according to CLP and DSD, the analogue substance is considered to be “not irritating” to rabbit skin regarding the oedema and erythema. Non-classification is likely to apply to the substance registered as well.
- Executive summary:
The primary skin irritation potential of the analogue substance was being investigated following the testing protocol as given in OECD guideline 404.
The analogue substance was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.The skin assessment of all animals was prevented by a marked yellow staining produced by the test item 1-48 hours after treatment and persisted as slight staining up to day 14. When assessable at the 72-hour observation a very slight erythema was noted in one female, only. No oedema was present in all animals during the whole observation period.
The mean score is usually calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately.
The skin assessment of all animals was prevented 1-48 hours after treatment by a yellow staining produced by the test item. Therefore, the mean score was not calculated.
No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the skin.
Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), the analogue substance is considered to be “not irritating” to rabbit skin regarding the oedema. Although the erythema assessment was not possible from the 1- to 48-hour observations due to a yellow staining, the test item is assumed to be “not irritating” for the erythema, as well.
Given the applicability of the proposed read across approach (see IUCLID chapter 13) non-classification is likely to apply to the substance registered as well.
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